Neurodegenerative DiseasesPeptiClearNCT05317871
Clearance Mechanisms in Atypical Neurodegenerative Diseases
An observational study of Neurodegenerative Diseases and Frontotemporal Degeneration, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
The project PeptiClear aims to investigate whether the blood-brain-barrier (BBB) and the glymphatic system are compromised in atypical neurodegenerative diseases, and whether Alzheimer´s disease (AD)-related copathology, vascular lesions or sleep disturbances modify the clinical picture or structural and/or functional… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Neurodegenerative Diseases, Frontotemporal Degeneration
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2022to Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Atypical neurodegerative diseases: Lewy-Body Spectrum Diseases, Progressive Supranuclear Palsy, Corticobasal Syndrome, Frontemporal Degeneration
Who may be able to join
- Diagnosis of Atypical Parkinsonian Disorders or Frontotemporal Dementia
- Able to provide written informed consent
- Unchanged pharmacotherapy within 4 days prior to the study specific assessments
- Fluent in German
Who cannot join
- Unable to give informed consent or has a legal guardian
- Other severe mental disorder, e.g. schizophrenia or bipolar affective disorder
- Clinically relevant depression
- Acute suicidality
- Current alcohol, drug or medication abuse
- History of severe traumatic brain injury within 3 months prior to inclusion
Show all 15Show fewer
- Structural lesions of the basal ganglia or brain stem
- Severe neurological disorder including (but not limited to) epilepsy, systemic disorders, stroke, repeated transient ischaemic attacks, increased brain intracranial pressure, normal pressure hydrocephalus
- Severe medical disorders including (but not limited to) heart failure, respiratory failure, uncontrolled severe arterial hypertension
- Electronic implants (e.g. cardiac pacemaker) or other MRI contraindication
- Renal failure > stage 3 (GFR < 30 mL/min)
- Pregnancy
- Unresolved malignancies within two years prior to inclusion
- Severe current infections or other chronic or systemic disorders
- Other circumstances which preclude participation based on the investigator's judgement
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Klinik und Poliklinik für Psychiatrie und Psychotherapie des LMU Klinikums
München, Bavaria, 80336
Robert Perneczky, Prof. Dr., +49 89 4400 55863, psy.alzheimerzentrum@med.uni-muenchen.de
Lena Burow, M.Sc., +49 89 4400 55898, lena.burow@med.uni-muenchen.de
About this study
Official title: Cerebral Clearance Mechanisms in Atypical Neurodegenerative Diseases: A Multi-modal Study on Lymphatic, Glymphatic and Blood-brain-barrier Function
The project PeptiClear aims to investigate whether the blood-brain-barrier (BBB) and the glymphatic system are compromised in atypical neurodegenerative diseases, and whether Alzheimer´s disease (AD)-related copathology, vascular lesions or sleep disturbances modify the clinical picture or structural and/or functional features of the diseases.
Read the detailed description
It is well established for the frequent sporadic (non-genetic) variant of Alzheimer´s disease (AD) that not the overproduction of a specific protein (Amyloid-beta - Aβ) is a major cause but rather the insufficient clearance of this protein from the central nervous system. On one hand, under physiological conditions, the interplay of the several cell types (cerebral endothelial cells, perivascular mural cells (pericytes), glial cells (astrocytes and microglia) and neurons) regulates the neuronal and glial cell environment and is crucial for cell function and survival. On the other hand, Aβ aggregates lead to BBB damage and activation of microglial cells. The BBB facilitates the clearance of proteins such as Aβ via the cerebrovascular system, but its association with other intracerebral Aβ drainage systems, such as the glympathic system, remains to be clarified. As the glymphatic system is mainly active during sleep, sleep disturbances could influence the clinical course. Concerning atypical neurodegenerative diseases, it is not clear whether tau or alpha-synuclein (alpha-syn) deposits also have a potential to damage the BBB. In AD Aβ aggregation and vascular changes give rise to insufficient protein clearance and thus contribute to AD pathogenesis in a synergistic fashion. However the role of copathology in atypical neurodegenerative diseases - which mainly consists of Alzheimer-related changes and vascular pathology - is elusive and remains to be clarified.
The prospective study cohort (N ~80) will include patients with Lewy Body spectrum disease, progressive supranuclear palsy, corticobasal syndrome and frontotemporal dementia. All study participants will undergo a detailed clinical and neuropsychological assessment according to a standardised protocol (i.a. magnet resonance imaging (MRI), positron emission tomography (PET), cerebrospinal fluid (CSF), actigraphy).
- Keywords
- Neurodegenerative diseases, Frontotemporal Degeneration, Clearance, Blood-brain-barrier, Sleep, Microglial activation, Glymphatic system
- Medical subject headings
- Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lewy Body Spectrum Diseases | Not described | |
| Progressive Supranuclear Palsy | Not described | |
| Corticobasal Syndrome | Not described | |
| Frontotemporal Degeneration | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disruption of the brain-blood-barrier between the subgroups
Name of Measurement: Ktrans; Measurement Tool: dynamic contrast imaging(DCI) sequence (MRI); Unit: min -1
Measured: Baseline
Clearance mechanisms and glymphatic or cerebral lymphatic system
Name of Measurement: Diffusion tensor imaging (DTI) Analysis along the perivascular space (ALPS); Measurement Tool: DTI MRI; Unit: mean (Dxpro, Dypro)/ mean (Dypro, Dzasc)
Measured: Baseline
Changes in circadian rhythms
Sleep Efficiency, proportional integration mode (PIM) ;Measurement Tool: Actigraphy; Units: counts
Measured: Baseline
Correlation between clinical symptoms, tau pathology and BBB disorder
Correlations between neuropsychological tests (e.g. Clinical Dementia Rating Sum of Boxes), CSF markers (pg/ml) and TAU PET, standardized uptake value ratio (SUVr) and Ktrans map
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start1 Apr 2022
- Primary completionApr 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neurodegenerative DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Perneczky, Ludwig-Maximilians - University of Munich
- Investigators
- Robert Perneczky, Prof. Dr., Principal investigator, Klinik und Poliklinik für Psychiatrie und Psychotherapie des LMU Klinikums
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05317871
- Sponsor's protocol ID
- 21-0106
- Acronym
- PeptiClear
- Status last verified
- Mar 2023
- First submitted
- 2 Nov 2021
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kurz C, Hattenkofer D, Pihale-Haug M, Hufnagel A, Gursel SU, Brendel M, Rauchmann BS, Levin J, Hoglinger G, Perneczky R. Head-to-head comparison of neurodegeneration biomarkers across two analytical platforms in Alzheimer's disease. Aging Clin Exp Res. 2026 Jun 25;38(1):157. doi: 10.1007/s40520-026-03420-5.
PubMed 42348024
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Clearance Mechanisms in Atypical Neurodegenerative Diseases: A Multi-modal Study on Lymphatic, Glymphatic and Blood-brain-barrier Function
- ClinicalTrials.gov ID
- NCT05317871
- Acronym / sponsor ID
- PeptiClear / 21-0106
- Keywords
- Neurodegenerative diseases, Frontotemporal Degeneration, Clearance, Blood-brain-barrier, Sleep, Microglial activation, Glymphatic system
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The project PeptiClear aims to investigate whether the blood-brain-barrier (BBB) and the glymphatic system are compromised in atypical neurodegenerative diseases, and whether Alzheimer´s disease (AD)-related copathology, vascular lesions or sleep disturbances modify the clinical picture or structural and/or functional features of the diseases.
Detailed description
It is well established for the frequent sporadic (non-genetic) variant of Alzheimer´s disease (AD) that not the overproduction of a specific protein (Amyloid-beta - Aβ) is a major cause but rather the insufficient clearance of this protein from the central nervous system. On one hand, under physiological conditions, the interplay of the several cell types (cerebral endothelial cells, perivascular mural cells (pericytes), glial cells (astrocytes and microglia) and neurons) regulates the neuronal and glial cell environment and is crucial for cell function and survival. On the other hand, Aβ aggregates lead to BBB damage and activation of microglial cells. The BBB facilitates the clearance of proteins such as Aβ via the cerebrovascular system, but its association with other intracerebral Aβ drainage systems, such as the glympathic system, remains to be clarified. As the glymphatic system is mainly active during sleep, sleep disturbances could influence the clinical course. Concerning atypical neurodegenerative diseases, it is not clear whether tau or alpha-synuclein (alpha-syn) deposits also have a potential to damage the BBB. In AD Aβ aggregation and vascular changes give rise to insufficient protein clearance and thus contribute to AD pathogenesis in a synergistic fashion. However the role of copathology in atypical neurodegenerative diseases - which mainly consists of Alzheimer-related changes and vascular pathology - is elusive and remains to be clarified.
The prospective study cohort (N ~80) will include patients with Lewy Body spectrum disease, progressive supranuclear palsy, corticobasal syndrome and frontotemporal dementia. All study participants will undergo a detailed clinical and neuropsychological assessment according to a standardised protocol (i.a. magnet resonance imaging (MRI), positron emission tomography (PET), cerebrospinal fluid (CSF), actigraphy).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lewy Body Spectrum Diseases | – | – |
| Progressive Supranuclear Palsy | – | – |
| Corticobasal Syndrome | – | – |
| Frontotemporal Degeneration | – | – |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Atypical neurodegerative diseases: Lewy-Body Spectrum Diseases, Progressive Supranuclear Palsy, Corticobasal Syndrome, Frontemporal Degeneration
Key inclusion criteria (4 listed)
- Diagnosis of Atypical Parkinsonian Disorders or Frontotemporal Dementia
- Able to provide written informed consent
- Unchanged pharmacotherapy within 4 days prior to the study specific assessments
- Fluent in German
Key exclusion criteria (15 listed)
- Unable to give informed consent or has a legal guardian
- Other severe mental disorder, e.g. schizophrenia or bipolar affective disorder
- Clinically relevant depression
- Acute suicidality
- Current alcohol, drug or medication abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disruption of the brain-blood-barrier between the subgroups
Time frame: Baseline
Name of Measurement: Ktrans; Measurement Tool: dynamic contrast imaging(DCI) sequence (MRI); Unit: min -1
Clearance mechanisms and glymphatic or cerebral lymphatic system
Time frame: Baseline
Name of Measurement: Diffusion tensor imaging (DTI) Analysis along the perivascular space (ALPS); Measurement Tool: DTI MRI; Unit: mean (Dxpro, Dypro)/ mean (Dypro, Dzasc)
Changes in circadian rhythms
Time frame: Baseline
Sleep Efficiency, proportional integration mode (PIM) ;Measurement Tool: Actigraphy; Units: counts
Correlation between clinical symptoms, tau pathology and BBB disorder
Time frame: Baseline
Correlations between neuropsychological tests (e.g. Clinical Dementia Rating Sum of Boxes), CSF markers (pg/ml) and TAU PET, standardized uptake value ratio (SUVr) and Ktrans map
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
- Derived from this study: PubMed 42348024Kurz C, Hattenkofer D, Pihale-Haug M, Hufnagel A, Gursel SU, Brendel M, Rauchmann BS, Levin J, Hoglinger G, Perneczky R. Head-to-head comparison of neurodegeneration biomarkers across two analytical platforms in Alzheimer's disease. Aging Clin Exp Res. 2026 Jun 25;38(1):157. doi: 10.1007/s40520-026-03420-5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Perneczky, Prof. Dr. principal investigator
Klinik und Poliklinik für Psychiatrie und Psychotherapie des LMU Klinikums
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurodegenerative Diseases and Frontotemporal Degeneration, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Perneczky, Prof. Dr. (+4989440055863, PSY.Alzheimerzentrum@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disruption of the brain-blood-barrier between the subgroups (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05317871, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2023.